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Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study (US EAP LHON)

Primary Purpose

Leber's Hereditary Optic Neuropathy

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Idebenone 150 MG Oral Tablet
Sponsored by
Santhera Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Leber's Hereditary Optic Neuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment.
  • Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient).

Exclusion Criteria:

  • Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial.
  • Patients who prematurely discontinued the LEROS study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2020
    Last Updated
    April 20, 2023
    Sponsor
    Santhera Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04381091
    Brief Title
    Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
    Acronym
    US EAP LHON
    Official Title
    Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Santhera Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study
    Detailed Description
    see above

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leber's Hereditary Optic Neuropathy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Idebenone 150 MG Oral Tablet
    Intervention Description
    idebenone 900 mg/day

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment. Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient). Exclusion Criteria: Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial. Patients who prematurely discontinued the LEROS study.

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

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